Mosapride

Gastrointestinal motility disorder is a common clinical digestive system problem. For a long time, there has been a lack of clinical treatment regimens with both safety and prokinetic selectivity, until the advent of 5-hydroxytryptamine 4 (5-HT4) receptor agonist drugs filled this gap. Mosapride, as a highly selective 5-HT4 receptor agonist, stimulates the 5-HT4 receptors on cholinergic interneurons in the gastrointestinal tract and the myenteric nerve plexus to promote the release of acetylcholine, thereby enhancing upper gastrointestinal motility. It does not stimulate dopamine D2 receptors, avoiding common adverse reactions of traditional prokinetic drugs such as extrapyramidal reactions and arrhythmia. Clinically, it is mainly used for functional dyspepsia with symptoms such as heartburn, belching, nausea, vomiting, early satiety and upper abdominal distension. It can also be used for gastroesophageal reflux disease, diabetic gastroparesis and gastric dysfunction in patients with partial gastrectomy. The applicable population covers adult patients with abnormal gastrointestinal motility of all age groups.

The prevalence of gastrointestinal diseases in China is as high as 23%~35%, among which motility disorder-related diseases account for more than 40%, driving the continuous expansion of the prokinetic drug market. In 2023, the overall market size of domestic prokinetic drugs exceeded 9 billion yuan. As the core variety of the second-generation prokinetic drugs, mosapride has a market share of 28% and maintains a compound annual growth rate of 7.2%. At present, the domestic mosapride preparation market is dominated by generic drugs, and more than 20 enterprises have obtained preparation approvals. Among them, mosapride citrate tablets, dispersible tablets and other dosage forms have been included in the national centralized procurement. The winning bid price has dropped by more than 80% compared with the original research drug, the accessibility of the primary market has been greatly improved, and the demand for API continues to release with the implementation of centralized procurement.

The original research enterprise of mosapride is Sumitomo Pharma Japan, and the original research brand name is "Gasmotin". Its core compound patent expired outside Japan in 2011, and the compound patent in China also expired in 2011. The main dosage form approved for the original research drug is tablet with a specification of 5mg, which has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. Up to now, there are 23 registration entries of mosapride citrate API on China CDE API Registration Platform, among which 18 are in the status of "A" (approved for use in marketed preparations). Multiple dosage forms such as mosapride citrate tablets, dispersible tablets, capsules and granules have been approved for marketing in China. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for mosapride API, which meet the declaration requirements of pharmacopoeias of various countries. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day, which can meet the full-process needs of pharmaceutical enterprises in R&D, quality research and compliance declaration. The products comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and comprehensively help enterprises shorten the R&D cycle and reduce the declaration risk.